WS/T 654-2019 in English

VALID

Safety management for medical devices

Issued on:2019-10-18
Implemented on:2020-05-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $270.00
$262.00

Standard No:	WS/T 654-2019
Document status:	VALID
Title in English:	Safety management for medical devices
Title in Chinese:	医疗器械安全管理
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2019-10-18
Implemented on:	2020-05-01
ICS Classification:	11.020-Medical Sciences and health care facilities in general
Chinese Classification:	C05-Medical science
Professional Classification:	WS-Hygiene
Related Keywords:	standard management dimension high-risk devices medical devices introduction analysis equipment management department risk classification risk management system three-level risk management structure
Related Topics:	Medical Device Laboratory Medical Device Laboratory Principles of Medical Devices Physiological instrument Medical Device Testing Medical Device Testing medical device personnel Sales of medical devices Medical Device Management Physiological instrument therapy National Medical Devices Testing medical devices treatment+ Medical Device Program List of medical devices medical safety box Medical device parameters medical tubing Medical device parameters Principles of Medical Devices Medical Device Disposal Methods Are Class II Medical Devices Safe? Three types of medical device management system List of Class II Medical Devices Clinical use of medical devices Medical Device Effectiveness Unqualified Medical Devices Medical device installation Medical devices are regulated by three levels Class II medical device use management Medical device outer box management Medical Device Life Medical Device Supervision 14th Five-Year Plan Cardiac Medical Devices Medical Device Country Flow Tube Medical Devices General Medical Devices medical security Medical Device Management General Devices (Biosafety) Medical device cybersecurity capabilities Medical device repair Medical device gas hose Medical device tubing dimensional inspection Medical device cooling holes

本标准规定了进入医疗机构的有源医疗器械在临床使用前及使用期间的安全管理要求，包括医疗机构医疗器械管理组织建立的架构、各级组织的职责、应建立的各种管理制度之要素、安全管理的方法等；同时规定了保障医疗器械安全和有效的性能检测、操作规范、维护保养等技术要求。
本标准适用于医疗机构临床使用的有源医疗器械的安全管理。

Introduction

Analysis of the core framework of the standard

Management dimension	High-risk devices	Medium-risk devices	Low-risk devices
Testing cycle	Quarterly key testing + semi-annual comprehensive testing	Semi-annual key testing + annual comprehensive testing	Annual testing
Personnel qualifications	Medical engineering professionals + operation assessment required		Basic training
File retention period	5 years after termination of use

Key Technical Requirements

1. Risk Management System

The standard requires medical institutions to establish a three-level risk management structure:

Management Organization: It must include the collaboration of the responsible leader, medical business department, and equipment management department
Risk Classification: Refer to Appendix B to classify pacemakers and other devices as high risk, and ultrasound diagnostic equipment and other devices as medium risk
Dynamic Assessment: Conduct risk analysis and evaluation of the entire device at least once a year

2. Performance Test Specifications

Take medical linear accelerator as an example:

The testing laboratory must meet GB 16895.24 Electrical safety requirements
Detection equipment must be calibrated regularly and the status must be marked
Detection records must include 12 elements such as environmental conditions and key parameters

Implementation suggestions

1. System construction path

Establish in stages:

Phase I	Improve basic systems such as acceptance and maintenance
Phase II	Establish emergency plans for adverse events
Phase III	Implement risk classification dynamic management

2. Status identification management

Appendix A of the standard clearly states:

Green certificate of conformity: Equipment within the validity period after testing
Red certificate of suspension: Equipment that failed the test
Yellow fault certificate: Equipment for temporary repair

3. Key points of personnel training

Three types of personnel need to be covered:

Managers: interpretation of policies and regulations
Engineering personnel: YY/T 0841 testing standard training
Operators: assessment of equipment-specific operations

More samples: NB/T 47013.2-2015 JC/T 2453-2018 YD/T 3934-2021

Sample only — not a preview of WS/T 654-2019

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